Signature Orthopedics Pty Limited

One device in the database

  • Model / Serial
    UDI: 09348215001926. Lot:78560.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - U.S. Nationwide and the country of Australia.
  • Product Description
    Signature Ceramic Femoral Head. Model Number: 111-152-621. || The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). || The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within || the Logical Acetabular Cups. || Product Usage: || Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement